CLINICALPROTOCOLANDDATAMANAGEMENT PROJECTSUMMARY/ABSTRACT TheClinicalProtocolandDataManagementOffice,knownatYaleUniversityastheYaleCancerCenter (YCC)ClinicalTrialsOffice(CTO),isthecentralmanagementandoperationsorganizationforallclinicaltrials atYCC.Itsprimarygoalsare:1)tofacilitateefficientactivationandconductoftherapeutictreatmenttrialsin canceracrossalldisciplinesatYale;?and2)toprovideoptimalinfrastructurefortheconductofsuchtrials, oversightofpersonnelthroughhighest-levelSOPsthatensureaccurateconductofprotocol-mandated proceduresanddatacapture,andfullregulatorycompliancewithalltrialaspects.Wehavemademajor progressingrowingtheCTOinfrastructuretosupportincreasedtreatmentinterventional(therapeutic)trial accrual,whichhasrisenfrom231subjectsinFY11toover800inFY15,16,and17.Thisgrowthhasincluded extendingourservicesto12community-basedSmilowCancerHospitalclinics(SmilowCancerHospitalCare Centers,orCCs)throughoutConnecticut.Thisimprovementhasallowedustoprovideseamlessclinicaltrials accessthroughouttheentireSmilowCancerHospital(SCH)networkandhasresultedinmorethan130 accrualsinFY16and17fromthesesites.TheCTOhasgrownfrom40to120employeesoverthelastgrant period,parallelingthisincreaseinaccrual.WehaverestructuredtheCTOsincethelastgrantperiodtoprovide greaterregulatoryconsistencyandquality,andtoprovidemoreclinic-baseddatacapture.Inaddition,wehave emphasizedQualityAssurance,withnewrecruitsandnewauditSOPs,aswellasincreasedreportingtoour DataSafetyMonitoringCommittee(DSMC).Wealsohavefocusedonminorityaccrualthroughouroutreach programs,includingthewidelyrecognizedOWN-ITProject(Dr.Silber).Wecontinuetogrowandincreaseour clinicaltrialseffortstoprovidepatientsthroughoutConnecticutwiththeopportunitytoparticipateinstate-of- the-artclinicalresearch.